Praxbind
- Product NDC
- 0597-0197
- 11-digit product format
- 005970197
- Labeler code
- 0597
- Product ID
- 0597-0197_9474d542-4726-4546-a768-10d418cdf5cc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- idarucizumab
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Application
- BLA761025
- Marketing category
- BLA
- Marketing start
- 2015-10-21
- Substance
- IDARUCIZUMAB
- Active strength
- 50 mg/mL
- Pharmacologic classes
- Antibodies, Monoclonal, Humanized [CS], Humanized Monoclonal Antibody Fragment [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Praxbind
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IDARUCIZUMAB | 50 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 97RWB5S1U6 |
| Rxcui | 1716195, 1716200 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0597-0197-05 | Praxbind | 2 in 1 CARTON | INJECTION | 2 | | 8 |
| 0597-0197-05 | Praxbind | 50 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 50 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0597-0197 | PRAXBIND (IDARUCIZUMAB) INJECTION [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20240208_c7400f8a-dcf4-a6df-6d07-983081b1bf34.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0597-0197-05 | 00597019705 | 2 VIAL, SINGLE-DOSE in 1 CARTON (0597-0197-05) / 50 mL in 1 VIAL, SINGLE-DOSE | 2015-10-21 | 0000-00-00 | No | No | Current |